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Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration (comPERFORMStud)

Primary Purpose

Renal Failure, End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Dialyser

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Hemodialysis, Hemodiafiltration, Renal replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

General:

Informed consent signed and dated by study patient and investigator/authorized physician
Minimum age of 18 years
Legally competent and able to understand the nature, risk, meaning, and consequences of the clinical trial (cf. MPG § 20 Sec. 2 Sentence 1 No. 1)
Chronic kidney disease stage 5D (end stage renal disease) on hemodiafiltration as extracorporeal renal replacement therapy

Study-specific:

On high volume online (>21 L/session substitution volume postdilution per session) hemodiafiltration (HDF), at least 4 h treatment time thrice weekly ≥3 month
Vascular access (fistula or graft) and high flow double lumen catheter which enables suitable effective blood flow rate (≥ 300 ml/min)

Exclusion Criteria:

General:

Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.)
Ongoing participation in an interventional clinical study during the preceding 30 days
Previous participation in this study
Pregnancy or lactation period
Patient is not able to give informed consent according to MPG § 20 Sec. 2 Sentence 1 No. 1

Study-specific:

Recurrent episodes of vascular access failure characterized by e.g. repeated cannulation problems or unstable blood flows within the last 2 months prior to study start (>3 times, respectively)
Single needle treatments
Catheter as vascular access (except high flow double lumen catheter)
Unstable patients (due to e.g. acute intercurrent disease like myocardial infarction, cerebrovascular accident, peripheral arterial occlusion, active malignant disease, use of antibiotics within the last 4 weeks)
Patients with heart failure (NYHA ≥ 3), COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension requiring intervention within the last 2 months prior to study start (>3 times, respectively)
Patients with known or suspected allergy to trial product and related products
Patients with chronic antiallergic medication due to immune-mediated disease
Planned absence from dialysis unit within the 4 weeks of study duration e.g. due to scheduled hospitalization, holidays or any other reason
Active HBV, HCV, HIV infection

Sites / Locations

Diakonissenkrankenhaus Flensburg
PHV-Dialysezentrum Goslar
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
PHV Dialysezentrum Kiel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hemodiafiltration HDF

Arm Description

Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)

Outcomes

Primary Outcome Measures

Removal rate of β2-microglobulin

Removal rate of β2-microglobulin in Plasma related to the albumin removal into the dialysate

Secondary Outcome Measures

Full Information

NCT ID

NCT04102280

First Posted

September 23, 2019

Last Updated

December 1, 2021

Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

Institut Dr. Schauerte (IDS)

1. Study Identification

Unique Protocol Identification Number

NCT04102280

Brief Title

Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

Acronym

comPERFORMStud

Official Title

Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration - comPERFORM Study (Comparative PERFORMance)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 29, 2019 (Actual)

Primary Completion Date

November 6, 2020 (Actual)

Study Completion Date

May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresenius Medical Care Deutschland GmbH

Collaborators

Institut Dr. Schauerte (IDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.

Detailed Description

The primary objective of this study is to test whether the FX P600 is non-inferior to the Xevonta Hi 15 dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration. The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure, End Stage Renal Disease

Keywords

Hemodialysis, Hemodiafiltration, Renal replacement therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hemodiafiltration HDF

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Dialyser

Intervention Description

Primary Outcome Measure Information:

Title

Removal rate of β2-microglobulin

Description

Removal rate of β2-microglobulin in Plasma related to the albumin removal into the dialysate

Time Frame

t=240 minutes of HDF

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: General: Informed consent signed and dated by study patient and investigator/authorized physician Minimum age of 18 years Legally competent and able to understand the nature, risk, meaning, and consequences of the clinical trial (cf. MPG § 20 Sec. 2 Sentence 1 No. 1) Chronic kidney disease stage 5D (end stage renal disease) on hemodiafiltration as extracorporeal renal replacement therapy Study-specific: On high volume online (>21 L/session substitution volume postdilution per session) hemodiafiltration (HDF), at least 4 h treatment time thrice weekly ≥3 month Vascular access (fistula or graft) and high flow double lumen catheter which enables suitable effective blood flow rate (≥ 300 ml/min) Exclusion Criteria: General: Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. any acute condition, e.g. infection or mental problem which might give reason for concern etc.) Ongoing participation in an interventional clinical study during the preceding 30 days Previous participation in this study Pregnancy or lactation period Patient is not able to give informed consent according to MPG § 20 Sec. 2 Sentence 1 No. 1 Study-specific: Recurrent episodes of vascular access failure characterized by e.g. repeated cannulation problems or unstable blood flows within the last 2 months prior to study start (>3 times, respectively) Single needle treatments Catheter as vascular access (except high flow double lumen catheter) Unstable patients (due to e.g. acute intercurrent disease like myocardial infarction, cerebrovascular accident, peripheral arterial occlusion, active malignant disease, use of antibiotics within the last 4 weeks) Patients with heart failure (NYHA ≥ 3), COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension requiring intervention within the last 2 months prior to study start (>3 times, respectively) Patients with known or suspected allergy to trial product and related products Patients with chronic antiallergic medication due to immune-mediated disease Planned absence from dialysis unit within the 4 weeks of study duration e.g. due to scheduled hospitalization, holidays or any other reason Active HBV, HCV, HIV infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Götz Ehlerding, Dr med

Organizational Affiliation

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diakonissenkrankenhaus Flensburg

City

Flensburg

ZIP/Postal Code

24939

Country

Germany

Facility Name

PHV-Dialysezentrum Goslar

City

Goslar

ZIP/Postal Code

38642

Country

Germany

Facility Name

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

PHV Dialysezentrum Kiel

City

Kiel

ZIP/Postal Code

24106

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

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